A Phase II, Multicenter, Double Blind, Double Dummy, Randomized, 2 Arms Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Source Chiesi Farmaceutici S.p.A.
Brief Summary

A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome

Overall Status Active, not recruiting
Start Date December 12, 2019
Completion Date January 30, 2021
Primary Completion Date November 14, 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Duration of treatment defined as the number of hours from first dose of study drug administration until the last dose of study drug up to 10 weeks after first dose
Secondary Outcome
Measure Time Frame
Time to first weaning, defined as the number of hours from first dose of study drug administration until the first dose reduction up to 10 weeks after first dose
Requirement for adjunctive drug therapy (phenobarbital) for signs of NOWS up to 10 weeks after first dose
Total hours of treatment with adjunctive therapy up to 10 weeks after first dose
Requirement for rescue doses (CHF6563 or morphine) up to 10 weeks after first dose
Percentage of total dose which is from rescue doses up to 10 weeks after first dose
Length of opioid related hospital stay, defined as number of days from day of birth until 48 hours after the final dose of drug treatment for NOWS up to 10 weeks plus 48 hours
Relapse of NOWS, defined as experiencing recurrence of significant signs of withdrawal up to 6 weeks after last dose
Incidence of readmissions, defined as readmission to hospital for NOWS relapse up to 6 weeks after last dose
Enrollment 99
Condition
Intervention

Intervention type: Drug

Intervention name: CHF6563

Description: Sublingual CHF6563 administration at starting dose of 10 µg/Kg q8

Arm group label: CHF6563

Intervention type: Drug

Intervention name: Morphine

Description: Oral morphine administration at starting dose of 0.07 mg/Kg q4

Arm group label: Morphine

Intervention type: Drug

Intervention name: CHF6563 matched placebo

Description: Sublingual CHF6563 matched placebo administration

Arm group label: Morphine

Intervention type: Drug

Intervention name: Morphine matched placebo

Description: Oral morphine matched placebo administration

Arm group label: CHF6563

Eligibility

Criteria:

Inclusion Criteria:

1. Written informed consent obtained by parents/legal representative(according to local regulation) prior to or after birth.

2. Birth weight ≥ 3rd centile for gestational age (GA), according to the CDC growth chart

3. Gestational age ≥ 36 weeks

4. Exposure to opioids during the last month of fetal life

5. Signs of neonatal opioid withdrawal syndrome requiring treatment, and the sum of 3 consecutive FNAST scores is ≥ 24 or a single score ≥ 12

Exclusion Criteria:

1. Familial history of prolonged QTc syndrome

2. Major congenital malformations or evidence of congenital infection

3. Signs of fetal alcohol spectrum disorders

4. Maternal alcohol abuse, defined as average of 3 or more drinks per week in the last 30 days

5. Medical illness at the time of randomization, including but not exclusively:

1. Neonatal hypoglycemia requiring intravenous glucose therapy

2. Neonatal respiratory illness requiring non-invasive or invasive respiratory support

3. Neonatal encephalopathy (including hypoxic ischemic encephalopathy or seizures

4. Severe hyperbilirubinemia-bilirubin at or above the exchange transfusion threshold as defined by the AAP

5. Severe elevation of serum aminotransferases (more than twice the upper limit of the age appropriate aminotransferases reference range of the investigational site).

6. Proven or suspected early onset neonatal infection which will require more than 48hours treatment with antibiotics

6. Unable to tolerate an oral or sublingual medication

7. Need for medications forbidden in this study protocol

8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

9. Participation in another clinical trial of any medicinal product, placebo, experimental medical device or biological substance conducted under the provisions of a protocol on the same therapeutic target. The participation in studies involving diagnostic devices or treatments for conditions other than NOWS and NAS may be permitted following an agreement with the Sponsor. Non-interventional observational studies are allowed

Gender: All

Minimum age: N/A

Maximum age: 7 Days

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Walter Kraft Principal Investigator Thomas Jefferson University
Location
facility
Thomas Jefferson University
Location Countries

United States

Verification Date

December 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CHF6563

Arm group type: Experimental

Description: Sublingual dose of CHF6563 and the corresponding oral dose of morphine matched placebo

Arm group label: Morphine

Arm group type: Active Comparator

Description: Oral dose of morphine and the corresponding sublingual dose of CHF6563 matched placebo.

Acronym NOWSHINE
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking description: double blind, double-dummy

Source: ClinicalTrials.gov